Appeal No. 1997-2532
Application No. 08/427,569
the predicted viral genome ... could be tentative, because the provirus analyzed ... is that
integrated in leukemia cells" (p. 3622, c. 2, first full para.).
Hogan discloses a method for preparing probes for use in hybridization assays
which
comprises constructing an oligonucleotide that is sufficiently complementary
to hybridize to a region of rRNA selected to be unique to a non-viral
organism or group of non-viral organisms sought to be detected, said region
of rRNA being selected by comparing one or more variable region rRNA
sequences of said non-viral organism or group of non-viral organisms with
one or more variable region rRNA sequences from one or more non-viral
organisms sought to be distinguished" (abstract).
Ratner determined the sequences for nucleotides 1-5184, including the long
terminal repeat (LTR), gag, protease gene, and pol sequences, of HTLV-1 isolates of
Caribbean and African origin (abstract; p. 924, c. 1, para 3; Fig. 1) and stated that
[t]he limited sequence variation among HTLV-1 isolates suggests that
diagnostic assays should be useful in detecting virtually all substrains of the
virus. The positions of sequence variation outlined here should assist in the
design of future diagnostic reagents. [P. 939, c. 2, para. 2.]
Stratagene describes two advantages of kits, convenience and quality control.
According to the examiner, it would have been obvious (a) to identify conserved
regions of the HTLV-1 sequence disclosed by Seiki or Ratner (b) using the "the
methodology of selection of particular primers as taught by Ratner or Hogan" (c) "to solve
the problem of specific detection of a variety of HTLV-1 species" using the hybridization
assay of Urdea (d) "since Ratner states 'The limited sequence variation among HTLV-1
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